On May 19, 2016 Laboratory Corporation of America Holdings (LabCorp) (NYSE:LH) reported the nationwide availability of the VENTANA PD-L1 (SP142) Assay as a complementary diagnostic for TECENTRIQ (atezolizumab), a new immunotherapy treatment for patients with urothelial cancer, the most common form of bladder cancer in the U.S (Press release, LabCorp, MAY 19, 2016, View Source [SID:1234512579]). The test was developed by Roche Diagnostics and was approved on May 18, 2016 by the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from treatment with Genentech’s TECENTRIQ (atezolizumab). The availability of this important new test demonstrates LabCorp’s commitment to provide world-class diagnostics to physicians and their patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"LabCorp is dedicated to improving health and improving lives through the introduction of new tests and by bringing innovative medicines to patients faster," said David P. King, LabCorp’s chairman and chief executive officer. "LabCorp is particularly focused on the development of immunotherapies and tests that pair with these medicines to change the way care is provided to cancer patients, and we are pleased to be among the first laboratories to offer the VENTANA PD-L1 (SP142) assay."

Bladder cancer is the most common malignancy of the urinary system and the ninth most common form of cancer worldwide. Despite urothelial (transitional cell) cancer being the most common form of bladder cancer in the U.S., no major new therapies have been introduced for it in the past 30 years. The availability of TECENTRIQ in combination with the PD-L1 (SP142) test has the potential to significantly improve the treatment of patients diagnosed with this form of cancer. In addition to identifying the PD-L1 protein on tumor infiltrating immune cells, the assay also offers a novel immune cell scoring algorithm that can aid physicians to identify patients for whom treatment with TECENTRIQ may be the right option.

"LabCorp already offers companion diagnostic and complementary diagnostic tests to help identify patients who may benefit from new, targeted immunotherapies for the treatment of melanoma and lung cancer," said Dr. Mark Brecher, LabCorp’s chief medical officer. "The PD-L1 (SP142) assay can help change the way care is provided by helping physicians better understand the potential benefits of treatment with TECENTRIQ for their patients with bladder cancer."

On May 19, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) and Baxalta Incorporated (NYSE: BXLT) today jointly reported the initiation of a Phase 1 clinical study of Merrimack’s oligoclonal EGFR (epidermal growth factor receptor) inhibitor, MM-151, in combination with ONIVYDE (irinotecan liposome injection) plus fluorouracil (5-FU) and leucovorin in patients with RAS wild-type metastatic colorectal cancer (Press release, Merrimack, MAY 19, 2016, View Source [SID:1234512576]). Data from a prior Phase 1 study of MM-151 supports further clinical evaluation of the investigational therapy in patients with metastatic colorectal cancer. The initiation of this study advances the development path for ONIVYDE.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Metastatic colorectal cancer remains a deadly disease with only 11% of patients surviving five years or longer," said Dr. Emily Chan, Principal Investigator, Associate Professor of Medicine and GI Medical Oncologist, Vanderbilt-Ingram Cancer Center. "As our understanding of the dynamics of cancer cells increases, we are able to develop and explore novel targeted combination therapies to combat this deadly disease. This study is a significant step forward toward addressing this unmet medical need, and providing a potential new treatment option to patients facing this deadly disease."

This Phase 1 study will assess the safety and tolerability of the combination of MM-151, a novel antibody mixture of three human antibodies designed to target EGFR which promotes tumor growth, and ONIVYDE, also known as MM-398 or "nal-IRI," plus 5-FU and leucovorin as first or second-line treatment in patients with RAS wild-type metastatic colorectal cancer.

"We are excited to initiate this Phase 1 clinical study, which will enable us to evaluate MM-151 in combination with the ONIVYDE regimen," said J. Marc Pipas, M.D., Medical Director at Merrimack. "Preclinically, MM-151 has shown superior inhibition of the EGFR pathway compared to FDA approved EGFR inhibitors. Combining MM-151 with the ONIVYDE regimen represents an exciting opportunity to investigate a potential new treatment regimen for patients with metastatic colorectal cancer."

The trial will determine the side effect profile of MM-151 in combination with ONIVYDE plus 5-FU and leucovorin and recommended dose for subsequent trials with this combination. Eligible patients for the study must have metastatic disease, have had no prior exposure to irinotecan or an EGFR inhibitor, and have received no more than one prior line of treatment for metastatic disease. Merrimack plans to conduct the study at multiple sites in the United States. Merrimack will be solely responsible for the funding and execution of the Phase 1 study. For more information, please visit www.clinicaltrials.gov.

Merrimack and Baxalta have entered into an exclusive licensing agreement to develop and commercialize ONIVYDE outside of the United States. PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize ONIVYDE in Taiwan and received the Taiwan FDA approval of ONIVYDE on October 22, 2015.

About MM-151

MM-151 is Merrimack’s wholly owned oligoclonal therapeutic mixture consisting of three fully-human monoclonal antibodies designed to bind and inhibit signaling of the epidermal growth factor receptor (EGFR). EGFR-mediated signaling promotes the growth and survival of cancer cells and has long been recognized as an important drug target in several types of cancer, including colon, lung, breast, pancreatic, and head and neck cancers. MM-151 has previously been tested in a Phase 1 dose-escalation clinical trial in patients with advanced solid tumors.

About ONIVYDE [pronounced \ ‘on – ih – vide \]

ONIVYDE (irinotecan liposome injection), also known as MM-398 or "nal-IRI," is a novel encapsulation of irinotecan in a liposomal formulation. The activated form of irinotecan is SN-38, which functions by inhibiting topoisomerase I (an essential enzyme involved in DNA transcription and replication) and promoting cell death. ONIVYDE was approved by the U.S. Food and Drug Administration in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. For full prescribing information, including Boxed WARNING, please visit www.ONIVYDE.com.

On May 19, 2016 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported that the United States Food and Drug Administration (FDA) granted Breakthrough Therapy designation to VYXEOS (also known as CPX-351) (Press release, Celator Pharmaceuticals, MAY 19, 2016, View Source [SID:1234512570]). VYXEOS is an investigational product in development as a treatment for AML and other blood cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Breakthrough Therapy designation is primarily based upon the positive results from the pivotal Phase 3 clinical trial in older patients with previously untreated high-risk (secondary) AML. The designation is for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). This designation includes the patient populations enrolled in the Phase 3 clinical trial.

The Phase 3 trial met its primary endpoint demonstrating a statistically significant improvement in overall survival. Data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting on Saturday, June 4th.

The median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving 7+3, representing a 3.61 month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3. The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.

Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS.

No substantial difference in Grade 3-5 adverse events was observed between VYXEOS and 7+3. In the intent-to-treat population, Grade 3-5, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events. In the intent-to-treat population, Grade 3-5, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.

"We are very happy the FDA granted Breakthrough Therapy designation for VYXEOS," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "The breadth of the designation, which includes all adults with t-AML and AML-MRC, is encouraging as AML patients are in need of advancements in treatment. We look forward to working with the FDA to bring VYXEOS to patients as quickly as possible."

FDA awards Breakthrough Therapy designation in order to expedite the development and review of new medicines that are intended to treat serious or life-threatening diseases when the therapy has demonstrated substantial improvement over available therapies on at least one clinically significant endpoint or when there is significant unmet medical need.

Celator plans to submit a New Drug Application (NDA) to the FDA by the end of the third quarter of 2016.

On May 19, 2016 BIND Therapeutics, Inc. (NASDAQ: BIND), a biotechnology company developing targeted and programmable therapeutics called ACCURINS, reported an agreement has been reached with its secured lender Hercules Technology III, L.P., an affiliate of Hercules Capital (NYSE: HTCG), for the use of cash collateral through July 8, 2016 subject to certain agreed upon terms and conditions (Press release, BIND Therapeutics, MAY 19, 2016, View Source [SID:1234512563]). As part of the agreement negotiated under BIND’s voluntary chapter 11 filing, the Company has agreed, among other things, to pay-down $4 million in principal on the existing principal loan balance of approximately $12.4 million.

“I am pleased that we were able to reach a mutual agreement with Hercules Capital that enables BIND to continue operations and continue exploring financial and strategic alternatives” said Andrew Hirsch, BIND’s president and chief executive officer. “Since our restructuring on April 6th, we have been actively evaluating avenues to raise additional capital, including through the capital markets, a strategic collaboration with one or more parties, or the license, sale or divestiture of some of our proprietary technologies, including a sale of the company. We appreciate Hercules’ continued willingness to work in partnership towards a mutually acceptable agreement which culminated in today’s agreement.”

“BIND Therapeutics has been a portfolio company of Hercules since 2010,” said Scott Bluestein, Hercules Chief Investment Officer. “Over the last several weeks, both pre and post petition, we worked tirelessly towards a resolution that would be mutually acceptable and allow the Company to drive towards its stated goal of exploring strategic alternatives following its April 6th announcement. We are thankful that the parties were able to reach agreement and look forward to what we hope to be the successful conclusion to the strategic process that is now underway.”

Documents related to the chapter 11 filing can be accessed at www.primeclerk.com/BIND.

On May 19, 2016 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported that negotiations with the Economic Committee on Health Care Products in France regarding pricing and reimbursement for Iclusig (ponatinib) have now concluded (Press release, Ariad, MAY 19, 2016, View Source [SID:1234512561]). As a result, ARIAD will record net product revenue related to cumulative shipments in France of approximately $25 million in the second quarter of 2016.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Iclusig has been available to patients in France since late 2012 through a pre-licensed sales mechanism called an ATU (temporary authorization of use). This mechanism allows patient access to potential life-saving drugs prior to full pricing and reimbursement approval.

About Iclusig (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.
Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.
Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.
Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Click here to view the EU Dear Healthcare Provider Letter (PDF).